BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE PULSE

    MDR report key: 3951921 · Received June 27, 2014

    Report

    Report Number
    3951921
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BUNNELL LIFE PULSE HIGH FREQUENCY VENTILATOR WAS NOT WORKING ON SIX MONTH OLD FEMALE PREMATURE INFANT IN NICU. THE NURSE CALLED THE RESPIRATORY THERAPIST TO TROUBLESHOOT. RECEIVED A VENTILATOR DEFAULT CODE. RESPIRATORY THERAPIST CALLED BUNNELL'S HOTLINE. BUNNELL TOLD THE RESPIRATORY THERAPIST TO RETEST AND STILL GOT THE VENTILATOR DEFAULT CODE 03 AFTER SEVERAL RETESTS. THE RESPIRATORY THERAPIST TOLD BUNNELL THAT THE SERVO PRESSURE WOULD NOT INCREASE. RESPIRATORY THERAPIST TOOK BUNNELL LIFE PULSE HIGH FREQUENCY VENTILATOR OUT OF SERVICE AND NOTIFIED BIOMEDICAL SERVICES. REPLACED WITH A BACKUP BUNNELL LIFE PULSE HIGH FREQUENCY VENTILATOR. NO UNTOWARD EFFECTS TO PREMATURE INFANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376631 LIFE PULSE VENTILATOR, HIGH FREQENCY LSZ BUNNELL, INC. 203A *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO